BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1841786 · Received September 22, 2010

    Report

    Report Number
    1423500-2010-03630
    Event Type
    Malfunction
    Date Received
    September 22, 2010
    Date of Event
    August 27, 2010
    Report Date
    August 27, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN ENGINEERING QUALITY REVIEW WAS COMPLETED FOR THIS REPORT OF AN INCOMPLETE PRIME. THE REPORTED CONDITION WAS NOT CONFIRMED DUE TO LACK OF PRODUCT SAMPLE. THE LOT NUMBER WAS UNKNOWN; THEREFORE, A BATCH REVIEW WAS NOT PERFORMED. BASED ON THE INFORMATION OBTAINED FROM BAXTER'S INVESTIGATION, THE ROOT CAUSE OF THE INCIDENT WAS NOT DETERMINED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED. SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A SYSTEM ERROR (SE) 2240 ALARM WAS IDENTIFIED IN THE LOG OF A RETURNED HOMECHOICE (HC) DEVICE. THE ALARM OCCURRED ON (B)(6) 2010. A SE 2240 (AIR IN SET) IS A NON-RECOVERABLE ALARM THAT OCCURS WHEN THE DEVICE HAS DETECTED AIR BEING DRAWN CONTINUOUSLY INTO THE DISPOSABLE. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    A HOME PATIENT (HP) REPORTED AIR BUBBLES IN THE PATIENT LINE DURING PRIME. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE HP TO REPRIME THE PATIENT LINE. THE HP AGAIN STATED SHE SAW A LOT OF AIR BUBBLES IN THE PATIENT LINE. THE TSR ADVISED THE HP TO LOWER THE PATIENT LINE BELOW THE HOMECHOICE DEVICE AND REPRIME. THE HP STATED SHE STILL SAW AIR BUBBLES. THE TSR ADVISED THE HP TO START OVER WITH NEW SUPPLIES. PRODUCT SURVEILLANCE FOLLOWED UP WITH THE HP'S NURSE VIA PHONE CALL; THE NURSE STATED THE PATIENT WAS FINE AND THREW AWAY THE SUPPLIES. THE PATIENT WAS ABLE TO CONTINUE THERAPY WITH THE NEW DISPOSABLES. THERE WAS NO PATIENT INJURY OR MEDIAL INTERVENTION REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOMATED PD SET W/CASSETTE4 PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR